Cyclophosphamide Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2013-09-16)
Oldest Current Product
2013-09-16
License(s)
NDA
RxNORM
ORAL CAPSULE\CYCLOPHOSPHAMIDE
FDAOB
ORAL\CAPSULE\CYCLOPHOSPHAMIDE
SPL Active
ORAL\CAPSULE\CYCLOPHOSPHAMIDE
SPL Moiety
ORAL\CAPSULE\CYCLOPHOSPHAMIDE ANHYDROUS

product(s) by strength(s)

cyclophosphamide 25 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540382NDARoxane Laboratories, Inc2013-09-16CYCLOPHOSPHAMIDEORALCAPSULENDA2038568135b917-882f-4b4c-99b7-fa8ea54af4bf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1691890382NDAAvera Mckennan Hospital2015-08-18CYCLOPHOSPHAMIDEORALCAPSULE000540382NDA2038564d188a0e-a2cc-49a4-abe9-a3b82f104267

cyclophosphamide 50 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540383NDARoxane Laboratories, Inc2013-09-16CYCLOPHOSPHAMIDEORALCAPSULENDA2038568135b917-882f-4b4c-99b7-fa8ea54af4bf

application(s)

#idtitleapplicantapprovedapproved drug
1NDA203856CYCLOPHOSPHAMIDEROXANE LABORATORIES INC2013-09-16NDA203856_001, NDA203856_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203856_001RXCYCLOPHOSPHAMIDE (25MG)ORALCAPSULEFalse2013-09-16CYCLOPHOSPHAMIDE
2NDA203856_002RXCYCLOPHOSPHAMIDE (50MG)ORALCAPSULETrue2013-09-16CYCLOPHOSPHAMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14d188a0e-a2cc-49a4-abe9-a3b82f104267 (view SPL)These highlights do not include all the information needed to use Cyclophosphamide Capsules safely and effectively. See full prescribing information for Cyclophosphamide Capsules. Cyclophosphamide Capsules Initial U.S. Approval: 1959prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-191691890382
28135b917-882f-4b4c-99b7-fa8ea54af4bf (view SPL)These highlights do not include all the information needed to use Cyclophosphamide Capsules safely and effectively. See full prescribing information for Cyclophosphamide Capsules. Cyclophosphamide Capsules Initial U.S. Approval: 1959prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-09-164000540382, 000540383

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII